Two US pharmaceutical industry groups note that they are generally supportive of the International Council for Harmonization (ICH) guideline on pediatric extrapolation in drug development but suggest ...

Mark Lebwohl, MD, details how he extrapolates clinical data in his decision-making when trying to treat patients with psoriasis. Ryan Haumschild, PharmD, MS, MBA: Given examples of some of the ...

A new draft guidance document quietly issued last week by the US Food and Drug Administration (FDA) is intended to explain how medical device manufacturers can show their devices are safe for use in ...

At the beginning of a new wave of an epidemic, extreme care should be used when extrapolating data to determine whether lockdowns are necessary, experts say. As the infectious virus causing the ...

When adult data were extrapolated to pediatric populations in drug development programs, more than 61% of those extrapolations were linked to new product labeling, according to study results.